A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy. - Full Text View

Purpose

This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.

Condition	Intervention	Phase
Diabetic Neuropathies	Drug: [S,S]-Reboxetine Drug: Placebo	Phase II

MedlinePlus related topics:

Diabetic Nerve Problems Peripheral Nerve Disorders

Drug Information available for:

Reboxetine Reboxetine mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in weekly average pain score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Responder rates (patients with a 30% reduction from baseline in weekly average pain score and patients with a 50% reduction from baseline in weekly average pain score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in weekly average sleep interference scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Modified Brief Pain Inventory-Short Form [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	330
Study Start Date:	December 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Placebo Oral tablet once a day dosing for 10 weeks.
2: Experimental	Drug: [S,S]-Reboxetine Oral tablet once a day dosing for 10 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female of any race at least 18 years of age
Diagnosis of painful, distal, symmetrical, sensori-motor polyneuropathy, which is due todiabetes, for at least 1 year
Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale

Exclusion Criteria:

Patients with significant hepatic impairment
Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain
Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy
Amputations other than toes
A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression
History of transient ischemic attack or stroke
Myocardial infarction or unstable angina within the past three months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625833

Show 57 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6061037
First Received:	February 14, 2008
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00625833
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuromuscular Diseases

Diabetic Neuropathies

Peripheral Nervous System Diseases

Diabetes Mellitus

Endocrine System Diseases

Pain

Endocrinopathy

Diabetes Complications

Reboxetine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic Uptake Inhibitors

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Psychotropic Drugs

Central Nervous System Agents

Pharmacologic Actions

Antidepressive Agents

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00625833